Skip to Page Content
Delaware.gov  |  Text OnlyGovernor | General Assembly | Courts | Elected Officials | State Agencies
 Photo: Featured Delaware Photo
 
 
 Phone Numbers Mobile Help Size Print Email

Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsJune 2017


Regulatory Flexibility Act Form

Authenticated PDF Version

16 DE Admin. Code 4465
Except as otherwise specifically provided, these regulations apply to all persons who receive, possess, use, transfer, own, or acquire any source of ionizing radiation. However, nothing in these regulations except for registration of radiation machine facilities/sources as specified in Regulation 4465 Part B shall apply to any person to the extent such person is subject to regulation by the Nuclear Regulatory Commission. See 4465 Parts C & G of these regulations which pertain to radioactive materials licensing and federal oversight.
"A1" means the maximum activity of special form radioactive material permitted in a Type A package. "A2" means the maximum activity of radioactive material, other than special form radioactive material, permitted in a Type A package. These values are either listed in Appendix A of Part T of these regulations, Table I, or may be derived in accordance with the procedure prescribed in Appendix A of Part T of these regulations.
"Absorbed dose" means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray (Gy) and the rad.
"Accelerator" means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of 1 MeV. For purposes of this definition, "particle accelerator" is an equivalent term.
"Accelerator-produced material" means any material made radioactive by a particle accelerator.
"Activity" means the rate of disintegration or transformation or decay of radioactive material. The units of activity are the becquerel (Bq) and the curie (Ci).
Address of use” means the building or buildings that are identified on the permit (license) and where radioactive materials may be produced, prepared, received, used, or stored.
"Adult" means an individual 18 or more years of age.
Agency means the Division of Public Health, Delaware Department of Health and Social Services.
"Agreement State" means any State with which the Nuclear Regulatory Commission or the Atomic Energy Commission has entered into an effective agreement under subsection 274b. of the Atomic Energy Act of 1954, as amended (73 Stat. 689).
"Airborne radioactive material" means any radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.
"Airborne radioactivity area" means a room, enclosure, or area in which airborne radioactive materials exist in concentrations:
"Airline respirator" (see"Supplied-air respirator (SAR)").
"Air-purifying respirator" means a respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.
As low as is reasonably achievable" (ALARA) means making every reasonable effort to maintain exposures to radiation as far below the dose limits in these regulations as is practical, consistent with the purpose for which the licensed or registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed or registered sources of radiation in the public interest.
"Assigned Protection Factor (APF)" means the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly trained and fitted users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.
"Atmosphere-supplying respirator" means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied-air respirators (SAR’s) and self-contained breathing apparatus (SCBA) units.
Authorized user means a practitioner of the healing arts who is identified as an authorized user on an Agency, Agreement State, Licensing State or the Nuclear Regulatory Commission license that authorizes the medical use of radioactive material.
"Background radiation" means radiation from cosmic sources, naturally occurring radioactive material, (which has not been technologically enhanced) including radon, except as a decay product of source or special nuclear material, and including global fallout as it exists in the environment from the testing of nuclear explosive devices, or from past nuclear accidents such as Chernobyl that contribute to background radiation and are not under the control of the licensee or registrant. "Background radiation" does not include sources of radiation from radioactive materials regulated by the Agency.
"Becquerel" (Bq) means the Standard Internationale (SI) unit of activity. One becquerel is equal to 1 disintegration or transformation per second (dps or tps).
"Bioassay" means the determination of kinds, quantities or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of these regulations, "radiobioassay" is an equivalent term.
"Brachytherapy" means a method of radiation therapy in which radiation sources are utilized to deliver a radiation dose at a distance of up to a few centimeters, by surface, intracavitary, intraluminal, or interstitial application.
"Byproduct material" means:
"Calendar quarter" means not less than 12 consecutive weeks nor more than 14 consecutive weeks. The first calendar quarter of each year shall begin in January and subsequent calendar quarters shall be so arranged such that no day is included in more than one calendar quarter and no day in any one year is omitted from inclusion within a calendar quarter. The method observed by the licensee or registrant for determining calendar quarters shall only be changed at the beginning of a year.
"Calibration" means the determination of (1) the response or reading of an instrument relative to a series of known radiation values over the range of the instrument, or (2) the strength of a source of radiation relative to a standard.
"CFR" means Code of Federal Regulations.
Chiropractic” means a drugless system of health care based on the principle that interference with the transmission of nerve impulses may cause disease, per Title 24 Delaware Code, Chapter 7, Board of Chiropractic, as amended.
"Collective dose" means the sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.
"Committed dose equivalent" (HT.50) means the dose equivalent to organs or tissues of reference (T) that will be received from an intake of radioactive material by an individual during the 50-year period following the intake.
"Committed effective dose equivalent" (HE.50) is the sum of the products of the weighting factors (wT) applicable to each of the body organs or tissues that are irradiated and the committed dose equivalent to each of these organs or tissues (HE,50 = Σ wT HT,50).
Controlled area” means an area, outside of a restricted but inside the site boundary, access to which can be limited by the licensee or registrant, for any reason.
Critical group” means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.
"Curie" means the traditional unit of quantity of activity. One curie (Ci) is that quantity of radioactive material, which decays at the rate of 3.7E+10 disintegrations or transformations per second (dps or tps).
"Deep dose equivalent" (Hd), which applies to external whole body exposure, means the dose equivalent at a tissue depth of 1 centimeter (1000 mg/cm2).
"Demand respirator" means an atmosphere-supplying respirator that admits breathing air to the face piece only when a negative pressure is created inside the facepiece by inhalation
Dentist” shall mean a person who is qualified to practice dentistry as prescribed in Title 24 Delaware Code, Chapter 11, Dentistry and Dental Hygiene, as amended.
"Department of Energy" means the Department of Energy established by Public Law 95-91, August 4, 1977, 91 Stat. 565, 42 U.S.C. Section 7101 as amended et seq., to the extent that the Department exercises functions formerly vested in the Atomic Energy Commission, its Chairman, members, officers and components and transferred to the Energy Research and Development Administration and to the Administrator thereof pursuant to sections 104(b), (c) and (d) of the Energy Reorganization Act of 1974 (Public Law 93-438, October 11, 1974, 88 Stat. 1233 at 1237, 42 U.S.C. 5814, effective January 19, 1975) and re-transferred to the Secretary of Energy pursuant to section 301(a) of the Department of Energy Organization Act (Public Law 95-91, August 4, 1977, 91 Stat. 565 at 577-578, 42 U.S.C. 7151, effective October 1, 1977 as amended.)
"Depleted uranium" means the source material uranium in which the isotope uranium-235 is less than 0.711 weight percent of the total uranium present. Depleted uranium does not include special nuclear material.
Discrete Source means a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.
"Disposable respirator" means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of-service-life renders it unsuitable for use. Examples of this type of respirator are a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus (SCBA).
"Distinguishable from background" means that the detectable concentration of a radionuclide is statistically different from the background concentration of that radionuclide in the vicinity of the site or, in the case of structures, in similar materials using adequate measurement technology, survey, and statistical techniques.
"Dose" is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, total organ dose equivalent, or total effective dose equivalent. For purposes of these regulations, "radiation dose" is an equivalent term.
"Dose equivalent (HT)" means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert (Sv) and rem.
"Dose limits" means the permissible upper bounds of radiation doses established in accordance with these regulations. For purposes of these regulations, "limits" is an equivalent term.
"Effective dose equivalent (HE)" means the sum of the products of the dose equivalent to the organ or tissue (HT) and the weighting factor (wT) applicable to each of the body organs or tissues that are irradiated (HE = Σ wTHT).
"Embryo/fetus" means the developing human organism from conception until the time of birth.
"Exposure" generally means being exposed to ionizing radiation or to radioactive material;
"Exposure Units" specifically as used in these regulations, the SI unit of exposure is coulomb per kilogram (C/kg), see Section A.9.1 of this Part for Units of Exposure and Dose.
"Exposure rate" means the exposure per unit of time, such as roentgen per minute or milliroentgen per hour.
"External dose" means that portion of the dose equivalent received from any source of radiation outside the body.
"Extremity" means hand, elbow, and arm below the elbow, foot, knee, and leg below the knee.
Facility” means the location, building vehicle, or complex under one administrative control, at which one or more radiation sources are installed, located and/or used.
"Filtering facepiece (dust mask)" means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps.
"Fit factor" means a quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn.
"Fit Test" means the use of a protocol to qualitatively evaluate the fit of a respirator on an individual.
"Former Atomic Energy Commission or Nuclear Regulatory Commission licensed facilities" means nuclear reactors, nuclear fuel reprocessing plants, uranium enrichment plants, or critical mass experimental facilities where Atomic Energy Commission or Nuclear Regulatory Commission licenses have been terminated.
"Generally applicable environmental radiation standards" means standards issued by the Environmental Protection Agency under the authority of the Atomic Energy Act of 1954, as amended, that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.
"Gray" (Gy) means the Standard Internationale (SI) unit of absorbed dose. One gray is equal to an absorbed dose of 1 joule per kilogram (100 rad).
"Hazardous waste" means those wastes designated as hazardous by the Environmental Protection Agency regulations in 40 CFR Part 261, as amended.
Healing arts includes but is not limited to the practice of medicine, surgery, dentistry, registered pharmacy, podiatry, osteopathy, chiropractic, or veterinary medicine or nursing.
Healing arts screening” means the testing of human beings using x-ray machines for the detection or evaluation of health indications when such tests are not specifically and individually ordered by a licensed practitioner of the healing arts legally authorized to prescribe such x-ray tests for the purpose of diagnosis or treatment.
"Helmet" means a rigid respiratory inlet covering that also provides head protection against impact and penetration.
"High radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of 1 mSv (0.1 rem) in 1 hour at 30 centimeters from any source of radiation or 30 centimeters from any surface that the radiation penetrates.
"Hood" means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.
"Human use" means the internal or external administration of radiation or radioactive material to human beings.
"Individual" means any human being.
"Individual monitoring" means the assessment of:
"Individual monitoring devices" means devices designed to be worn by a single individual for the assessment of dose equivalent. For purposes of these regulations, "personnel dosimeter" and "dosimeter" are equivalent terms. Examples of individual monitoring devices are film badges, thermoluminescence dosimeters (TLDs), pocket ionization chambers, optically stimulated luminescence (OSL) dosimeters and personal (lapel) air sampling devices.
"Inspection" means an official examination or observation including, but not limited to, tests, surveys, and monitoring to determine compliance with rules, regulations, orders, requirements, and conditions of the Agency.
"Instrument traceability" (for ionizing radiation measurements) means the ability to show that an instrument has been calibrated at specified time intervals using a national standard or a transfer standard. If a transfer standard is used, the calibration must be at a laboratory accredited by a program, which requires continuing participation in measurement quality assurance with the National Institute of Standards and Technology, or other equivalent national or international program.
"Interlock" means a device arranged or connected such that the occurrence of an event or condition is required before a second event or condition can occur or continue to occur.
"Internal dose" means that portion of the dose equivalent received from radioactive material taken into the body.
"JRCECT" means Joint Review Committee on Education in Cardiovascular Technology
JRCNMT means Joint Review Committee on Nuclear Medicine Technology
"JRCERT" means Joint Review Committee on Education in Radiologic Technology
"Lens dose equivalent (LDE)" means the external exposure to the lens of the eye as the dose equivalent at a tissue depth of 0.3 centimeter (300 mg/cm2).
"License" means a license issued by the US Nuclear Regulatory Commission, Agreement State, or the Agency, in accordance with applicable federal or state regulations, as amended.
Licensed Practitioner” means a physician licensed to practice medicine, dentistry, podiatry, chiropractic, osteopathy, or veterinary medicine in this state.
"Licensed Practitioner" means an individual licensed to practice medicine, dentistry, podiatry, chiropractic, osteopathy, advanced practice nursing, or veterinary medicine in this state.
"Licensed [or registered] material" means radioactive material received, possessed, used, transferred or disposed of under a general or specific license [or registration] issued by the Agency.
"Licensee" means the holder of a license.
"Limits" [See "Dose limits"].
"Loose-fitting facepiece" means a respiratory inlet covering that is designed to form a partial seal with the face.
"Lost or missing source of radiation" means licensed [or registered] source of radiation whose location is unknown. This definition includes, but is not limited to, radioactive material that has been shipped but has not reached its planned destination and whose location cannot be readily traced in the transportation system.
"Major processor" means a user processing, handling, or manufacturing radioactive material exceeding Type A quantities as unsealed sources or material, or exceeding 4 times Type B quantities as sealed sources, but does not include nuclear medicine programs, universities, industrial radiographers, or small industrial programs. Type A and B quantities are defined in T.2 of these regulations.
"Member of the public" means any individual except when that individual is receiving an occupational dose.
"Minor" means an individual less than 18 years of age.
Misadministration” means an event that meets the criteria in 4465 Part X, Therapeutic Radiation Machines, Section 5.2 of these regulations.
"Monitoring" means the measurement of radiation, radioactive material concentrations, surface area activities or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses. For purposes of these regulations, "radiation monitoring" and "radiation protection monitoring" are equivalent terms.
"Natural radioactivity" means radioactivity of naturally occurring nuclides.
"Negative pressure respirator (tight fitting)" means a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator.
"NORM" means any naturally occurring radioactive material. It does not include byproduct, source, or special nuclear material.
"NRC" means the US Nuclear Regulatory Commission or its duly authorized representatives.
Notice of Violation” means a written statement of one or more alleged infringements of a legally binding requirement. The notice normally requires the licensee, registrant or other permit holder to provide a written statement describing the following:
"Occupational dose" means the dose received by an individual in the course of employment in which the individual's assigned duties for the licensee or registrant involve exposure to sources of radiation, whether or not the sources of radiation are in the possession of the licensee, registrant, or other person. Occupational dose does not include doses received from background radiation, or from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with U.S. Nuclear Regulatory Commission Regulations, from voluntary participation in medical research programs, or as a member of the public.
Office of Engineering means the office in the Delaware Division of Public Health that reviews radiation shielding plans and/or design plans and issues an Approval to Construct letter for new radiation source facilities or rooms.
Office of Radiation Control means the office in the Delaware Division of Public Health which carries out the Delaware Radiation Control Regulations, issues radiation source facility registration permits, and performs on-site inspections of new and existing radiation machine facilities to determine compliance.
Owner/Leasee” means the person/individual who owns/leases the radiation source. An out-of-state owner shall authorize a manager to sign the application form.
"Package" means the packaging together with its radioactive contents as presented for transport.
"Particle accelerator" [See "Accelerator"].
"Person" means any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, agency, political subdivision of this State, any other State or political subdivision or agency thereof, and any legal successor, representative, agent, or agency of the foregoing, [but shall not include federal government agencies].
"Personnel monitoring equipment" [See "Individual monitoring devices"].
"Physician" means an allopathic doctor of medicine and surgery or a doctor of osteopathic medicine and surgery who is registered and certified to practice medicine pursuant to Title 24 Delaware Code, Chapter 17, Medical Practice Act, as amended.
Podiatrist” means a person who is qualified to practice podiatry and is licensed under Title 24 Delaware Code, Chapter 5, Podiatry, as amended.
"Positive pressure respirator" means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.
"Powered air-purifying respirator (PAPR)" means an air-purifying respirator that uses a blower to force the ambient air through air-purifying elements to the inlet covering.
"Pressure demand respirator" means a positive pressure atmosphere-supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.
Principal Supervisor” means the State-Licensed Practitioner responsible for initiating use of x-ray equipment or other device generating ionizing radiation in the healing arts.
"Protective apron" means an apron made of radiation-attenuating materials used to reduce exposure to radiation.
"Public dose" means the dose received by a member of the public from exposure to sources of radiation released by the licensee or registrant, or to any other source of radiation under the control of the licensee or registrant. Public dose does not include occupational dose, or doses received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with U.S. Nuclear Regulatory Commission Regulations, or from voluntary participation in medical research programs.
Qualified expert means an individual who has satisfactorily fulfilled the training and experience requirements consistent with achieving a level of competency sufficient to function effectively in the position for which registration is sought. Such individuals must demonstrate to the satisfaction of the Agency their qualifications, for example, individuals certified in the appropriate field by the American Board of Radiology, or the American Board of Health Physics, or the American Board of Medical Physics, or those having equivalent qualifications. With reference to the calibration of radiation therapy equipment, an individual, in addition to the above qualifications, must be qualified in accordance with 4465 Part F and 4465 Part X of these regulations, as amended.
Qualified Medical Physicist means an individual qualified in accordance with Regulation 4465, Part X, Therapeutic Radiation Machines, Section 3.4, as amended. means an individual who meets each of the following credentials:
1. Has earned a master's and/or doctoral degree in physics, medical physics, biophysics, radiological physics, medical health physics, or equivalent disciplines from an accredited college or university; and
"Qualitative fit test (QLFT)" means a pass/fail fit test to assess the adequacy of respirator fit that relies on the individual’s response to the test agent.
"Quality factor" (Q) means the modifying factor, listed in Tables I and II of A.13, that is used to derive dose equivalent from absorbed dose.
"Quantitative fit test (QNFT)" means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.
"Rad" means the traditional unit of absorbed dose. One rad is equal to an absorbed dose of 100 erg per gram or 0.01 joule per kilogram (0.01 gray).
"Radiation" means alpha particles, beta particles, gamma rays, x rays, neutrons, high-speed electrons, high-speed protons, and other particles capable of producing ions. For purposes of these regulations, ionizing radiation is an equivalent term. Radiation, as used in these regulations, does not include non-ionizing radiation, such as radiowaves or microwaves, visible, infrared, or ultraviolet light.
"Radiation area" means any area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.05 mSv (0.005 rem) in 1 hour at 30 centimeters from the source of radiation or from any surface that the radiation penetrates.
"Radiation dose" [See "Dose"].
"Radiation machine" means any device capable of producing ionizing radiation except those devices with radioactive material as the only source of radiation.
Radiation Safety Officer” or RSO for a radiation machine facility means an individual assigned to perform RSO duties who has training and experience in the safe and effective use of radiation machines, their potential radiation hazards, and emergency precautions applicable to the type of activity or facility to which the RSO is assigned.
"Radiation Technician" means any individual who has not graduated from an approved program in radiation technology, but has passed an Authority approved examination.
"Radiation Technologist" means any individual who has successfully completed a JRCERT/JRCCVT approved program in radiation technology and has passed a national certification examination in his/her field of specialization.
"Radiation Technology" means the use of a radioactive substance or equipment emitting ionizing radiation on humans for diagnostic or therapeutic purposes.
"Radioactive material" means any solid, liquid or gas which emits radiation spontaneously.
"Radioactivity" means the transformation of unstable atomic nuclei by the emission of radiation.
"Radiobioassay" [See "Bioassay"].
"Registrant" means any person who is registered with the Agency and is legally obligated to register with the Agency pursuant to these regulations and the Act.
"Registration" means registration with the Agency in accordance with the regulations adopted by the Agency.
"Regulations of the Department of Transportation" means the regulations in 49 CFR Parts 100-189, as amended.
"Rem" means the traditional unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rad multiplied by the quality factor. (1 rem = 0.01 Sv)
"Research and development" means (1) theoretical analysis, exploration, or experimentation; or (2) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials, and processes. Research and development does not include the internal or external administration of radiation or radioactive material to human beings in the healing arts.
"Residual radioactivity" means radioactivity in structures, materials, soils, groundwater, and other media at a site resulting from activities under the licensee’s control. This includes radioactivity from all licensed and unlicensed sources used by the licensee, but excludes background radiation. It also includes radioactive materials remaining at the site as a result of routine or accidental releases of radioactive materials at the site and previous burials at the site, even if those burials were made in accordance with the provisions of Part D of these regulations.
"Restricted area" means an area, access to which is limited by the licensee or registrant for the purpose of protecting individuals against undue risks from exposure to sources of radiation. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area.
"Roentgen" means the traditional unit of exposure. One roentgen (R) equals 2.58E-4 coulombs per kilogram of air (see "Exposure" and Part A.9.1 of this part.)
State Radiation Control Act or “the Act” means Title 16 Delaware Code, Chapter 74, Radiation Control, as amended.
"Sealed source" means any encapsulated radioactive material, which has been constructed in such a manner as to prevent the escape of any radioactive material.
"Sealed Source and Device Registry (SSD)" means the national registry that contains the registration certificates, maintained by the Nuclear Regulatory Commission (NRC), that summarize the radiation safety information for sealed sources and devices, and describe the licensing and use conditions approved for the product.
"Self-contained breathing apparatus (SCBA)" means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.
"Shallow dose equivalent" (Hs), which applies to the external exposure of the skin or an extremity, means the dose equivalent at a tissue depth of 0.007 centimeter (7 mg/cm2) averaged over the contiguous 10 square centimeters of skin receiving the highest exposure.
"SI" means the abbreviation for Standard Internationale, the International Metric System of Measurement.
"Sievert" means the Standard Internationale (SI) unit of any of the quantities expressed as dose equivalent. The dose equivalent in sievert is equal to the absorbed dose in gray multiplied by the quality factor. (1 Sv = 100 rem)
"Source material" means:
"Source material milling" means any activity that results in the production of byproduct material as defined by definition (2) of byproduct material, of this part.
"Source of radiation" means any radioactive material or any device or equipment emitting, or capable of producing, radiation.
"Source traceability" means the ability to show that a radioactive source has been calibrated either by the national standards laboratory of the National Institute of Standards and Technology, or by a laboratory which participates in a continuing measurement quality assurance program with National Institute of Standards and Technology or other equivalent national or international program.
"Special form radioactive material" means radioactive material that satisfies the following conditions:
"Special nuclear material" means:
"Special nuclear material in quantities not sufficient to form a critical mass" means uranium enriched in the isotope U-235 in quantities not exceeding 350 grams of contained U-235; uranium-233 in quantities not exceeding 200 grams; plutonium in quantities not exceeding 200 grams; or any combination of them in accordance with the following formula: For each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified above for the same kind of special nuclear material. The sum of such ratios for all of the kinds of special nuclear material in combination shall not exceed 1. For example, the following quantities in combination would not exceed the limitation and are within the formula:
Standard Internationale (SI) means the international metric systems of measurement.
"Supplied-air respirator (SAR)" means an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user.
"Survey" means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal, or presence of sources of radiation. When appropriate, such evaluation includes, but is not limited to, tests, physical examinations, and measurements of levels of radiation or concentrations of radioactive material present.
"Test" means the process of verifying compliance with an applicable regulation.
"These regulations" means all parts of The Delaware Radiation Control Regulations 4465, as amended.
"Tight-fitting facepiece" means a respiratory inlet covering that forms a complete seal with the face.
"Total effective dose equivalent" (TEDE) means the sum of the deep dose equivalent for external exposures and the committed effective dose equivalent for internal exposures.
"Total organ dose equivalent" (TODE) means the sum of the deep dose equivalent and the committed dose equivalent to the organ receiving the highest dose as described in D.1107a.vi. of these regulations.
"Traceable to a National Standard" [See "Instrument traceability" or "Source traceability"].
"Unrefined and unprocessed ore" means ore in its natural form prior to any processing such as grinding, roasting, beneficiating, or refining.
"Unrestricted area" means an area, access to which is neither limited nor controlled by the licensee or registrant. For purposes of these regulations, "uncontrolled area" is an equivalent term.
"User seal check (fit check)" means an action conducted by the respirator user to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure check, irritant smoke check, or isoamyl acetate check.
"Very high radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose in excess of 5 Gy (500 rad) in 1 hour at 1 meter from a source of radiation or 1 meter from any surface that the radiation penetrates.12/
Veterinarian” shall mean a person who has received a degree in veterinary medicine from a school of veterinary medicine, per Title 24 Delaware Code, Chapter 33, Veterinarians, as amended.
"Waste" means those low-level radioactive wastes that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level waste has the same meaning as in the Low-Level Radioactive Waste Policy Act, P.L. 96-573, as amended by P.L. 99-240, effective January 15, 1986; that is, radioactive waste (a) not classified as high-level radioactive waste, spent nuclear fuel, or byproduct material as defined in Section 11e.(2) of the Atomic Energy Act, as amended (uranium or thorium tailings and waste) and (b) classified as low-level radioactive waste consistent with existing law and in accordance with (a) by the Nuclear Regulatory Commission.
"Waste handling licensees" mean persons licensed to receive and store radioactive wastes prior to disposal and/or persons licensed to dispose of radioactive waste.
"Week" means 7 consecutive days starting on Sunday.
"Whole body" means, for purposes of external exposure, head, trunk including male gonads, arms above the elbow, or legs above the knee.
"Worker" means an individual engaged in activities under a license or registration issued by the Agency and controlled by a licensee or registrant, but does not include the licensee or registrant.
"Working level" (WL) means any combination of short-lived radon daughters in 1 liter of air that will result in the ultimate emission of 1.3E+5 MeV of potential alpha particle energy. The short-lived radon daughters of radon-222 are polonium-218, lead-214, bismuth-214, and polonium-214; and those of radon-220 are polonium-216, lead-212, bismuth-212, and polonium-212.
"Working level month" (WLM) means an exposure to 1 working level for 170 hours. 2,000 working hours per year divided by 12 months per year is approximately equal to 170 hours per month.
"Year" means the period of time beginning in January used to determine compliance with the provisions of these regulations. The licensee or registrant may change the starting date of the year used to determine compliance by the licensee or registrant provided that the change is made at the beginning of the year. If a licensee or registrant changes in a year, the licensee or registrant shall assure that no day is omitted or duplicated in consecutive years.
6.2 Impounding. Sources of radiation shall be subject to impoundment pursuant to Title 16 Delaware Code, Section 7415 of the State Radiation Control Act, as amended.
a/ Absorbed dose in gray equal to 1 Sv or the absorbed dose in rad equal to 1 rem.
(Neutrons cm-2 rem -1)
Dose Equivalentb/ (Neutrons cm-2 Sv-1)
a/ Value of quality factor (Q) at the point where the dose equivalent is maximum in a 30-centimeter diameter cylinder tissue-equivalent phantom.
b/ Monoenergetic neutrons incident normally on a 30-centimeter diameter cylinder tissue-equivalent phantom.
Agency means the Division of Public Health, Delaware Department of Health and Social Services.
CFR means Code of Federal Regulations.
Chiropractic” means a drugless system of health care based on the principle that interference with the transmission of nerve impulses may cause disease, per 24 Del.C., Ch. 7, Board of Chiropractic, as amended.
Certificate of Approval to Construct” means a document stipulating that work will be done in accordance to the plans and specifications as approved by the Office of Engineering. If at any point after the issuance of a certificate of Approval To Construct there are any changes made to the plans, the Office of Engineering must be immediately notified for them to take appropriate action.
Certificate of Approval to Operate means a document indicating that requirements for operation of a new radiation machine facility have been approved by the Office of Radiation Control, following a pre-operational, on-site inspection.
Dentist” shall mean a person who is qualified to practice dentistry as prescribed in 24 Del.C., Ch. 11, Dentistry and Dental Hygiene, as amended.
Facility means the location, building, vehicle, or complex under one administrative control, at which one or more radiation sources are installed, located and/or used.
Healing arts includes but is not limited to the practice of medicine, surgery, dentistry, registered pharmacy, podiatry, osteopathy, chiropractic, veterinary medicine or nursing.
kVP or Peak Tube Potential, means the maximum value of the potential difference across the x-ray tube during an exposure. This value is usually included in manufacturer’s technical specification for an x-ray device.
Licensed Practitioner” means a physician an individual licensed to practice medicine, dentistry, podiatry, chiropractic, osteopathy, or veterinary medicine in this state.
Manager means the individual working at the facility who is authorized by the owner to sign the application form as the applicant.
Office of Engineering means the office in the Delaware Division of Public Health which reviews radiation shielding plans, and issues approval for construction of new radiation machine facilities or rooms.
Office of Radiation Control means the office in the Delaware Division of Public Health which carries out the Delaware Radiation Control Regulations, issues radiation source facility registration permits, and performs on-site inspections of new and existing radiation machine facilities to determine compliance.
Owner/Leasee” means the person/individual who owns/leases the radiation source. An out-of-state owner shall authorize a manager working at the facility to sign the application form.
"Physician" means an allopathic doctor of medicine and surgery or a doctor of osteopathic medicine and surgery who is registered and certified to practice medicine pursuant to 24 Del.C., Ch. 17, Medical Practice Act, as amended.
Podiatrist” means a person who is qualified to practice podiatry and is licensed under 24 Del.C., Ch. 5, Podiatry, as amended.
Principal Supervisor” means the Licensed Practitioner responsible for initiating use of x-ray equipment or other device generating ionizing radiation in the healing arts.
Qualified Expert” means an individual who has satisfactorily fulfilled the training and experience requirements consistent with achieving a level of competency sufficient to function effectively in the position for which registration is sought. Such individuals must demonstrate to the satisfaction of the Agency their qualifications, for example, individuals certified in the appropriate field by the American Board of Radiology, or the American Board of Health Physics, or the American Board of Medical Physics, or those having equivalent qualifications. With reference to the calibration of radiation therapy equipment, an individual, in addition to the above qualifications, must be qualified in accordance with 4465 Part F and 4465 Part X of these regulations, as amended.
Qualified Medical Physicist means an individual qualified in accordance with 4465, Part X, Therapeutic Radiation Machines, of these regulations. who meets each of the following credentials:
Radiation Source see source of radiation.
Radiation Safety Officer or RSO for a radiation machine facility means an individual assigned to perform radiation safety duties who has training and experience in the safe and effective use of radiation machines, their potential radiation hazards, and emergency precautions applicable to the type of activity or facility to which the RSO is assigned.
Radiation Service Provider means company or person who provides radiation services to registered radiation source facilities in Delaware, see Section 9.0 of this Part.
Source of Radiation” means any radioactive material or any device or equipment emitting, or capable of producing, ionizing radiation.
Storage means a condition in which a device or source is not being used for an extended period of time, and has been made inoperable and shall be tagged as out of service.
Veterinarian shall mean a person who has received a degree in veterinary medicine from a school of veterinary medicine, per 24 Del.C. Ch. 33, Veterinarians, as amended.
7.1 In addition to the requirements of Section 6.0 of this Part, the applicant shall submit the following information:
7.1.1 An established main location where the machine(s), records, etc. will be maintained for inspection. This shall be a street address, not a post office box number.
7.1.2 A sketch or description of the normal configuration of each radiation machine's use, including the operator's position and any ancillary personnel's location during exposures. If a mobile van is used with a fixed unit inside, furnish the floor plan indicating protective shielding and the operator's location; and
7.1.3 A current copy of the applicant's operating and safety procedures including radiological practices for protection of patients, operators, employees, and the general public.
No person, in any advertisement, shall refer to the fact that he or his facility is registered with the Agency pursuant to the provisions of Part B, sections Section 6.0 or 9.0, and no person shall state or imply that any activity under such registration has been approved by the Agency.
(a) The operator shall be allotted not less than 0.70 m2 (7.5 square feet) of unobstructed floor space in the booth;
(2) Regardless of size or shape, at least 0.09 m2 (1 square foot) of the window area must be centered no less than 0.6 m (2 feet) from the open edge of the booth and no less than 1.5 m (5.0 feet) from the floor;
"A1" means the maximum activity of special form radioactive material permitted in a Type A package.
"A2" means the maximum activity of radioactive material, other than special form radioactive material, permitted in a Type A package.
Absorbed dose” means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray (Gy) and the rad.
Accelerator” means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of 1 MeV. For purposes of this definition, "particle accelerator" is an equivalent term.
Accelerator-produced material” means any material made radioactive by a particle accelerator.
Activity” means the rate of disintegration or transformation or decay of radioactive material. The units of activity are the becquerel (Bq) and the curie (Ci).
Address of use” means the building or buildings that are identified on the permit (license) and where radioactive materials may be produced, prepared, received, used, or stored.
"Adult" means an individual 18 or more years of age.
Agency” means the Division of Public Health, Delaware Department of Health and Social Services.
Agreement State” means any State with which the Nuclear Regulatory Commission or the Atomic Energy Commission has entered into an effective agreement under subsection 274b. of the Atomic Energy Act of 1954, as amended (73 Stat. 689).
Airborne radioactive material” means any radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.
Airborne radioactivity area” means a room, enclosure, or area in which airborne radioactive materials exist in concentrations:
Airline respirator” (see "Supplied-air respirator (SAR)").
Air-purifying respirator” means a respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.
Annual limit on intake (ALI)” means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the reference man that would result in a committed effective dose equivalent of 5 rems (0.05 Sv) or a committed dose equivalent to 50 rems (0.5 Sv) to any individual organ or tissue. (ALI values for intake by ingestion and by inhalation of selected radionuclides are given in Appendix B of this regulation.
As low as is reasonably achievable” (ALARA) means making every reasonable effort to maintain exposures to radiation as far below the dose limits in these regulations as is practical, consistent with the purpose for which the licensed or registered activity is undertaken, taking into account the state of technology, the economics of improvements in relation to state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed or registered sources of radiation in the public interest.
Assigned Protection Factor (APF)” means the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly trained and fitted users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.
Atmosphere-supplying respirator” means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied-air respirators (SAR’s) and self-contained breathing apparatus (SCBA) units.
Authorized user” means a practitioner of the healing arts who is identified as an authorized user on an Agency, Agreement State, Licensing State or the Nuclear Regulatory Commission license that authorizes the medical use of radioactive material.
Background radiation” means radiation from cosmic sources, naturally occurring radioactive material, (which has not been technologically enhanced) including radon, except as a decay product of source or special nuclear material, and including global fallout as it exists in the environment from the testing of nuclear explosive devices, or from past nuclear accidents such as Chernobyl that contribute to background radiation and are not under the control of the licensee or registrant. "Background radiation" does not include sources of radiation from radioactive materials regulated by the Agency.
"Becquerel" (Bq) means the Standard Internationale (SI) unit of activity. One becquerel is equal to 1 disintegration or transformation per second (dps or tps).
"Bioassay" means the determination of kinds, quantities or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of these regulations, "radiobioassay" is an equivalent term.
"Brachytherapy" means a method of radiation therapy in which radiation sources are utilized to deliver a radiation dose at a distance of up to a few centimeters, by surface, intracavitary, intraluminal, or interstitial application.
"Byproduct material" means:
Calendar quarter” means not less than 12 consecutive weeks nor more than 14 consecutive weeks. The first calendar quarter of each year shall begin in January and subsequent calendar quarters shall be so arranged such that no day is included in more than one calendar quarter and no day in any one year is omitted from inclusion within a calendar quarter. The method observed by the licensee or registrant for determining calendar quarters shall only be changed at the beginning of a year.
Calibration” means the determination of (1) the response or reading of an instrument relative to a series of known radiation values over the range of the instrument, or (2) the strength of a source of radiation relative to a standard.
CFR” means Code of Federal Regulations.
Chiropractic” means a drugless system of health care based on the principle that interference with the transmission of nerve impulses may cause disease, per Title 24 Delaware Code, Chapter 7, Board of Chiropractic, as amended.
Class (or lung class or inhalation class)” means a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W, or Y, which applies to a range of clearance half-times: for Class D (Days) of less than 10 days, for Class W (Weeks) from 10 to 100 days, and for Class Y (Years) of greater than 100 days.
Collective dose” means the sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.
Committed dose equivalent” (HT.50) means the dose equivalent to organs or tissues of reference (T) that will be received from an intake of radioactive material by an individual during the 50-year period following the intake.
Committed effective dose equivalent” (HE.50) is the sum of the products of the weighting factors (wT) applicable to each of the body organs or tissues that are irradiated and the committed dose equivalent to each of these organs or tissues (HE,50 = Σ wT HT,50).
Constraint (dose constraint)” means a value above which specified licensee actions are required.
Controlled area” means an area, outside of a restricted but inside the site boundary, access to which can be limited by the licensee or registrant, for any reason.
Critical group” means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.
Curie” means the traditional unit of quantity of activity. One curie (Ci) is that quantity of radioactive material, which decays at the rate of 3.7E+10 disintegrations or transformations per second (dps or tps).
Declared pregnant woman” means a woman who has voluntarily informed the licensee, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant.
Deep dose equivalent” (Hd), which applies to external whole body exposure, means the dose equivalent at a tissue depth of 1 centimeter (1000 mg/cm2).
Demand respirator” means an atmosphere-supplying respirator that admits breathing air to the face piece only when a negative pressure is created inside the facepiece by inhalation
Dentist” shall mean a person who is qualified to practice dentistry as prescribed in Title 24 Delaware Code, Chapter 11, Dentistry and Dental Hygiene, as amended.
Department of Energy” means the Department of Energy established by Public Law 95-91, August 4, 1977, 91 Stat. 565, 42 U.S.C. Section 7101 as amended et seq., to the extent that the Department exercises functions formerly vested in the Atomic Energy Commission, its Chairman, members, officers and components and transferred to the Energy Research and Development Administration and to the Administrator thereof pursuant to sections 104(b), (c) and (d) of the Energy Reorganization Act of 1974 (Public Law 93-438, October 11, 1974, 88 Stat. 1233 at 1237, 42 U.S.C. 5814, effective January 19, 1975) and re-transferred to the Secretary of Energy pursuant to section 301(a) of the Department of Energy Organization Act (Public Law 95-91, August 4, 1977, 91 Stat. 565 at 577-578, 42 U.S.C. 7151, effective October 1, 1977 as amended.)
"Depleted uranium" means the source material uranium in which the isotope uranium-235 is less than 0.711 weight percent of the total uranium present. Depleted uranium does not include special nuclear material.
Derived air concentration (DAC)” means the concentration of a given radionuclide in air which, if breathed by the reference man for a working year of 2,000 hours under conditions of light work (inhalation rate 1.2 cubic meters of air per hour), results in an intake of one ALI. DAC values are given in Appendix B of this regulation.
Discrete Source” means a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.
"Disposable respirator" means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of-service-life renders it unsuitable for use. Examples of this type of respirator are a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus (SCBA).
"Distinguishable from background" means that the detectable concentration of a radionuclide is statistically different from the background concentration of that radionuclide in the vicinity of the site or, in the case of structures, in similar materials using adequate measurement technology, survey, and statistical techniques.
"Dose" is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, total organ dose equivalent, or total effective dose equivalent. For purposes of these regulations, "radiation dose" is an equivalent term.
"Dose equivalent (HT)" means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert (Sv) and rem.
"Dose limits" means the permissible upper bounds of radiation doses established in accordance with these regulations. For purposes of these regulations, "limits" is an equivalent term.
"Effective dose equivalent (HE)" means the sum of the products of the dose equivalent to the organ or tissue (HT) and the weighting factor (wT) applicable to each of the body organs or tissues that are irradiated (HE = Σ wTHT).
"Embryo/fetus" means the developing human organism from conception until the time of birth.
"Exposure" generally means being exposed to ionizing radiation or to radioactive material;
"Exposure Units" specifically as used in these regulations, the SI unit of exposure is coulomb per kilogram (C/kg), see Section 9.1 of Part A for Units of Exposure and Dose.
"Exposure rate" means the exposure per unit of time, such as roentgen per minute or milliroentgen per hour.
"External dose" means that portion of the dose equivalent received from any source of radiation outside the body.
External Source” means all ionizing radiation sources that could present exposure or external dose to an individual.
"Extremity" means hand, elbow, and arm below the elbow, foot, knee, and leg below the knee.
Facility” means the location, building vehicle, or complex under one administrative control, at which one or more radiation sources are installed, located and/or used.
"Filtering facepiece (dust mask)" means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps.
"Fit factor" means a quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn.
"Fit Test" means the use of a protocol to qualitatively evaluate the fit of a respirator on an individual.
"Former Atomic Energy Commission or Nuclear Regulatory Commission licensed facilities" means nuclear reactors, nuclear fuel reprocessing plants, uranium enrichment plants, or critical mass experimental facilities where Atomic Energy Commission or Nuclear Regulatory Commission licenses have been terminated.
"Generally applicable environmental radiation standards" means standards issued by the Environmental Protection Agency under the authority of the Atomic Energy Act of 1954, as amended, that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.
"Gray" (Gy) means the Standard Internationale (SI) unit of absorbed dose. One gray is equal to an absorbed dose of 1 joule per kilogram (100 rad).
"Hazardous waste" means those wastes designated as hazardous by the Environmental Protection Agency regulations in 40 CFR Part 261, as amended.
Healing arts” includes but is not limited to the practice of medicine, surgery, dentistry, registered pharmacy, podiatry, osteopathy, chiropractic, or veterinary medicine or nursing.
Healing arts screening” means the testing of human beings using x-ray machines for the detection or evaluation of health indications when such tests are not specifically and individually ordered by a licensed practitioner of the healing arts legally authorized to prescribe such x-ray tests for the purpose of diagnosis or treatment.
"Helmet" means a rigid respiratory inlet covering that also provides head protection against impact and penetration.
"High radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of 1 mSv (0.1 rem) in 1 hour at 30 centimeters from any source of radiation or 30 centimeters from any surface that the radiation penetrates.
"Hood" means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.
"Human use" means the internal or external administration of radiation or radioactive material to human beings.
"Individual" means any human being.
"Individual monitoring" means the assessment of:
"Individual monitoring devices" means devices designed to be worn by a single individual for the assessment of dose equivalent. For purposes of these regulations, "personnel dosimeter" and "dosimeter" are equivalent terms. Examples of individual monitoring devices are film badges, thermoluminescence dosimeters (TLDs), pocket ionization chambers, optically stimulated luminescence (OSL) dosimeters and personal (lapel) air sampling devices.
"Inspection" means an official examination or observation including, but not limited to, tests, surveys, and monitoring to determine compliance with rules, regulations, orders, requirements, and conditions of the Agency.
"Instrument traceability" (for ionizing radiation measurements) means the ability to show that an instrument has been calibrated at specified time intervals using a national standard or a transfer standard. If a transfer standard is used, the calibration must be at a laboratory accredited by a program, which requires continuing participation in measurement quality assurance with the National Institute of Standards and Technology, or other equivalent national or international program.
"Interlock" means a device arranged or connected such that the occurrence of an event or condition is required before a second event or condition can occur or continue to occur.
"Internal dose" means that portion of the dose equivalent received from radioactive material taken into the body.
"JRCECT" means Joint Review Committee on Education in Cardiovascular Technology
JRCNMT” means Joint Review Committee on Nuclear Medicine Technology
"JRCERT" means Joint Review Committee on Education in Radiologic Technology
"Lens dose equivalent (LDE)" means the external exposure to the lens of the eye as the dose equivalent at a tissue depth of 0.3 centimeter (300 mg/cm2).
"License" means a license issued by the US Nuclear Regulatory Commission, Agreement State, or the Agency, in accordance with applicable federal or state regulations, as amended.
"Licensed [or registered] material" means radioactive material received, possessed, used, transferred or disposed of under a general or specific license [or registration] issued by the Agency.
Licensed Practitioner” means an individual licensed to practice medicine, dentistry, podiatry, chiropractic, osteopathy, advanced practice nursing, or veterinary medicine in this state.
"Licensee" means the holder of a license.
"Limits" [See "Dose limits"].
"Loose-fitting facepiece" means a respiratory inlet covering that is designed to form a partial seal with the face.
"Lost or missing source of radiation" means licensed [or registered] source of radiation whose location is unknown. This definition includes, but is not limited to, radioactive material that has been shipped but has not reached its planned destination and whose location cannot be readily traced in the transportation system.
"Major processor" means a user processing, handling, or manufacturing radioactive material exceeding Type A quantities as unsealed sources or material, or exceeding 4 times Type B quantities as sealed sources, but does not include nuclear medicine programs, universities, industrial radiographers, or small industrial programs. Type A and B quantities are defined in T.2 of these regulations.
"Member of the public" means any individual except when that individual is receiving an occupational dose.
"Minor" means an individual less than 18 years of age.
Misadministration” means an event that meets the criteria in 4465 Part X, Therapeutic Radiation Machines, Section 5.2 of these regulations.
"Monitoring" means the measurement of radiation, radioactive material concentrations, surface area activities or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses. For purposes of these regulations, "radiation monitoring" and "radiation protection monitoring" are equivalent terms.
"Natural radioactivity" means radioactivity of naturally occurring nuclides.
"Negative pressure respirator (tight fitting)" means a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator.
"NORM" means any naturally occurring radioactive material. It does not include byproduct, source, or special nuclear material.
Notice of Violation” means a written statement of one or more alleged infringements of a legally binding requirement. The notice normally requires the licensee, registrant or other permit holder to provide a written statement describing the following:
"NRC" means the US Nuclear Regulatory Commission or its duly authorized representatives.
"Occupational dose" means the dose received by an individual in the course of employment, education or training, in which the individual's assigned duties for the licensee or registrant involve exposure to sources of radiation, whether or not the sources of radiation are in the possession of the licensee, registrant, or other person. Occupational dose does not include doses received from background radiation, or from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with U.S. Nuclear Regulatory Commission Regulations, from voluntary participation in medical research programs, or as a member of the public.
Office of Engineering” means the office in the Delaware Division of Public Health that reviews radiation shielding plans and/or design plans and issues an Approval to Construct letter for new radiation source facilities or rooms.
Office of Radiation Control” means the office in the Delaware Division of Public Health which carries out the Delaware Radiation Control Regulations, issues radiation source facility registration permits, and performs on-site inspections of new and existing radiation machine facilities to determine compliance.
Owner/Leasee” means the person/individual who owns/leases the radiation source. An out-of-state owner shall authorize a manager to sign the application form.
"Package" means the packaging together with its radioactive contents as presented for transport.
"Particle accelerator" [See "Accelerator"].
"Person" means any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, agency, political subdivision of this State, any other State or political subdivision or agency thereof, and any legal successor, representative, agent, or agency of the foregoing, [but shall not include federal government agencies].
"Personnel monitoring equipment" [See "Individual monitoring devices"].
"Physician" means an allopathic doctor of medicine and surgery or a doctor of osteopathic medicine and surgery who is registered and certified to practice medicine pursuant to Title 24 Delaware Code, Chapter 17, Medical Practice Act, as amended.
Planned special exposure” means an infrequent exposure to radiation, separate from and in addition to the annual dose limits.
Podiatrist” means a person who is qualified to practice podiatry and is licensed under Title 24 Delaware Code, Chapter 5, Podiatry, as amended.
"Positive pressure respirator" means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.
"Powered air-purifying respirator (PAPR)" means an air-purifying respirator that uses a blower to force the ambient air through air-purifying elements to the inlet covering.
"Pressure demand respirator" means a positive pressure atmosphere-supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.
Principal Supervisor” means the State-Licensed Practitioner responsible for initiating use of x-ray equipment or other device generating ionizing radiation in the healing arts.
"Protective apron" means an apron made of radiation-attenuating materials used to reduce exposure to radiation.
"Public dose" means the dose received by a member of the public from exposure to sources of radiation released by the licensee or registrant, or to any other source of radiation under the control of the licensee or registrant. Public dose does not include occupational dose, or doses received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with U.S. Nuclear Regulatory Commission Regulations, or from voluntary participation in medical research programs.
Qualified expert” means an individual who has satisfactorily fulfilled the training and experience requirements consistent with achieving a level of competency sufficient to function effectively in the position for which registration is sought. Such individuals must demonstrate to the satisfaction of the Agency their qualifications, for example, individuals certified in the appropriate field by the American Board of Radiology, or the American Board of Health Physics, or the American Board of Medical Physics, or those having equivalent qualifications. With reference to the calibration of radiation therapy equipment, an individual, in addition to the above qualifications, must be qualified in accordance with 4465 Part F and 4465 Part X of these regulations, as amended.
Qualified Medical Physicist” means an individual qualified in accordance with Regulation 4465, Part X, Therapeutic Radiation Machines, Section 3.4, as amended. who meets each of the following credentials:
Qualitative fit test (QLFT)" means a pass/fail fit test to assess the adequacy of respirator fit that relies on the individual’s response to the test agent.
"Quality factor" (Q) means the modifying factor, listed in Tables I and II of A.13, that is used to derive dose equivalent from absorbed dose.
"Quantitative fit test (QNFT)" means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.
"Rad" means the traditional unit of absorbed dose. One rad is equal to an absorbed dose of 100 erg per gram or 0.01 joule per kilogram (0.01 gray).
"Radiation" means alpha particles, beta particles, gamma rays, x rays, neutrons, high-speed electrons, high-speed protons, and other particles capable of producing ions. For purposes of these regulations, ionizing radiation is an equivalent term. Radiation, as used in these regulations, does not include non-ionizing radiation, such as radiowaves or microwaves, visible, infrared, or ultraviolet light.
"Radiation area" means any area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.05 mSv (0.005 rem) in 1 hour at 30 centimeters from the source of radiation or from any surface that the radiation penetrates.
"Radiation dose" [See "Dose"].
"Radiation machine" means any device capable of producing ionizing radiation except those devices with radioactive material as the only source of radiation.
Radiation Safety Officer” or RSO for a radiation machine facility means an individual assigned to perform RSO duties who has training and experience in the safe and effective use of radiation machines, their potential radiation hazards, and emergency precautions applicable to the type of activity or facility to which the RSO is assigned.
"Radiation Technician" means any individual who has not graduated from an approved program in radiation technology, but has passed an Authority approved examination.
"Radiation Technologist" means any individual who has successfully completed a JRCERT/JRCCVT approved program in radiation technology and has passed a national certification examination in his/her field of specialization.
"Radiation Technology" means the use of a radioactive substance or equipment emitting ionizing radiation on humans for diagnostic or therapeutic purposes.
"Radioactive material" means any solid, liquid or gas which emits radiation spontaneously.
"Radioactivity" means the transformation of unstable atomic nuclei by the emission of radiation.
"Radiobioassay" [See "Bioassay"].
"Registrant" means any person who is registered with the Agency and is legally obligated to register with the Agency pursuant to these regulations and the Act.
Registration" means registration with the Agency in accordance with the regulations adopted by the Agency.
"Regulations of the Department of Transportation" means the regulations in 49 CFR Parts 100-189, as amended.
"Rem" means the traditional unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rad multiplied by the quality factor. (1 rem = 0.01 Sv)
"Research and development" means (1) theoretical analysis, exploration, or experimentation; or (2) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials, and processes. Research and development does not include the internal or external administration of radiation or radioactive material to human beings in the healing arts.
"Residual radioactivity" means radioactivity in structures, materials, soils, groundwater, and other media at a site resulting from activities under the licensee’s control. This includes radioactivity from all licensed and unlicensed sources used by the licensee, but excludes background radiation. It also includes radioactive materials remaining at the site as a result of routine or accidental releases of radioactive materials at the site and previous burials at the site, even if those burials were made in accordance with the provisions of Part D of these regulations.
"Restricted area" means an area, access to which is limited by the licensee or registrant for the purpose of protecting individuals against undue risks from exposure to sources of radiation. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area.
"Roentgen" means the traditional unit of exposure. One roentgen (R) equals 2.58E-4 coulombs per kilogram of air (see "Exposure" and Part A.9.1 of this part.)
State Radiation Control Act” or “the Act” means Title 16 Delaware Code, Chapter 74, Radiation Control, as amended.
"Sealed source" means any encapsulated radioactive material, which has been constructed in such a manner as to prevent the escape of any radioactive material.
"Sealed Source and Device Registry (SSD)" means the national registry that contains the registration certificates, maintained by the Nuclear Regulatory Commission (NRC), that summarize the radiation safety information for sealed sources and devices, and describe the licensing and use conditions approved for the product.
"Self-contained breathing apparatus (SCBA)" means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.
"Shallow dose equivalent" (Hs), which applies to the external exposure of the skin or an extremity, means the dose equivalent at a tissue depth of 0.007 centimeter (7 mg/cm2) averaged over the contiguous 10 square centimeters of skin receiving the highest exposure.
"SI" means the abbreviation for Standard Internationale, the International Metric System of Measurement.
"Sievert" means the Standard Internationale (SI) unit of any of the quantities expressed as dose equivalent. The dose equivalent in sievert is equal to the absorbed dose in gray multiplied by the quality factor. (1 Sv = 100 rem)
"Source material" means:
"Source material milling" means any activity that results in the production of byproduct material as defined by definition (2) of byproduct material, of this part.
"Source of radiation" means any radioactive material or any device or equipment emitting, or capable of producing, radiation.
"Source traceability" means the ability to show that a radioactive source has been calibrated either by the national standards laboratory of the National Institute of Standards and Technology, or by a laboratory which participates in a continuing measurement quality assurance program with National Institute of Standards and Technology or other equivalent national or international program.
"Special form radioactive material" means radioactive material that satisfies the following conditions:
"Special nuclear material" means:
"Special nuclear material in quantities not sufficient to form a critical mass" means uranium enriched in the isotope U-235 in quantities not exceeding 350 grams of contained U-235; uranium-233 in quantities not exceeding 200 grams; plutonium in quantities not exceeding 200 grams; or any combination of them in accordance with the following formula:
Standard Internationale (SI)” means the international metric systems of measurement.
"Supplied-air respirator (SAR)" means an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user.
"Survey" means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal, or presence of sources of radiation. When appropriate, such evaluation includes, but is not limited to, tests, physical examinations, and measurements of levels of radiation or concentrations of radioactive material present.
"Test" means the process of verifying compliance with an applicable regulation.
"These regulations" means all parts of The Delaware Radiation Control Regulations 4465, as amended.
"Tight-fitting facepiece" means a respiratory inlet covering that forms a complete seal with the face.
"Total effective dose equivalent" (TEDE) means the sum of the deep dose equivalent for external exposures and the committed effective dose equivalent for internal exposures.
"Total organ dose equivalent" (TODE) means the sum of the deep dose equivalent and the committed dose equivalent to the organ receiving the highest dose as described in subsection 39.1.6 of these regulations.
"Traceable to a National Standard" [See "Instrument traceability" or "Source traceability"].
"Unrefined and unprocessed ore" means ore in its natural form prior to any processing such as grinding, roasting, beneficiating, or refining.
"Unrestricted area" means an area, access to which is neither limited nor controlled by the licensee or registrant. For purposes of these regulations, "uncontrolled area" is an equivalent term.
"User seal check (fit check)" means an action conducted by the respirator user to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure check, irritant smoke check, or isoamyl acetate check.
"Very high radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose in excess of 500 rads (5 grays) in 1 hour at 1 meter from a source of radiation or 1 meter from any surface that the radiation penetrates.22/
Veterinarian” shall mean a person who has received a degree in veterinary medicine from a school of veterinary medicine, per Title 24 Delaware Code, Chapter 33, Veterinarians, as amended.
"Waste" means those low-level radioactive wastes that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level waste has the same meaning as in the Low-Level Radioactive Waste Policy Act, P.L. 96-573, as amended by P.L. 99-240, effective January 15, 1986; that is, radioactive waste (a) not classified as high-level radioactive waste, spent nuclear fuel, or byproduct material as defined in Section 11e.(2) of the Atomic Energy Act, as amended (uranium or thorium tailings and waste) and (b) classified as low-level radioactive waste consistent with existing law and in accordance with (a) by the Nuclear Regulatory Commission.
"Waste handling licensees" mean persons licensed to receive and store radioactive wastes prior to disposal and/or persons licensed to dispose of radioactive waste.
"Week" means 7 consecutive days starting on Sunday.
"Whole body" means, for purposes of external exposure, head, trunk including male gonads, arms above the elbow, or legs above the knee.
"Worker" means an individual engaged in activities under a license or registration issued by the Agency and controlled by a licensee or registrant, including but not limited to employees, but does not include the licensee or registrant.
"Working level" (WL) means any combination of short-lived radon daughters in 1 liter of air that will result in the ultimate emission of 1.3E+5 MeV of potential alpha particle energy. The short-lived radon daughters of radon-222 are polonium-218, lead-214, bismuth-214, and polonium-214; and those of radon-220 are polonium-216, lead-212, bismuth-212, and polonium-212.
"Working level month" (WLM) means an exposure to 1 working level for 170 hours. 2,000 working hours per year divided by 12 months per year is approximately equal to 170 hours per month.
"Year" means the period of time beginning in January used to determine compliance with the provisions of these regulations. The licensee or registrant may change the starting date of the year used to determine compliance by the licensee or registrant provided that the change is made at the beginning of the year. If a licensee or registrant changes in a year, the licensee or registrant shall assure that no day is omitted or duplicated in consecutive years.
Records of tests for leakage or contamination of sealed sources required by Part D, Section 15.0 shall be kept on file in accordance with the facility radioactive material license.
When a licensee or registrant is required, pursuant to Part D, Sections 47.0, 48.0, or D.2206 22.6 to report to the Agency any exposure of an identified occupationally exposed individual, or an identified member of the public, to radiation or radioactive material, the licensee shall also provide a copy of the report submitted to the Agency to the individual. This report must be transmitted at a time no later than the transmittal to the Agency.
"Accessible surface" means the external surface of the enclosure or housing of the radiation producing machine as provided by the manufacturer.
"Accessory component" means:
"Air kerma" means kerma in air (see definition of Kerma).
"Air kerma rate (AKR)" means the air kerma per unit time.
"Aluminum equivalent" means the thickness of type 1100 aluminum alloy (The nominal chemical composition of type 1100 aluminum is 99.00 percent minimum aluminum, 0.12 percent copper.) affording the same attenuation, under specified conditions, as the material in question.
"Articulated joint" means a joint between two separate sections of a tabletop which joint provides the capacity of one of the sections to pivot on the line segment along which the sections join.
"Assembler" means any person engaged in the business of assembling, replacing, or installing one or more components into an x-ray system or subsystem. The term includes the owner of an x-ray system or his or her employee or agent who assembles components into an x-ray system that is subsequently used to provide professional or commercial services.
"Attenuation block" means a block or stack, having dimensions 20 centimeters by 20 centimeters by 3.8 centimeters, of type 1100 aluminum alloy (The nominal chemical composition of type 1100 aluminum is 99.00 percent minimum aluminum, 0.12 percent copper.) or other materials having equivalent attenuation.
"Automatic exposure control (AEC)" means a device which automatically controls one or more technique factors in order to obtain at a preselected location(s) a required quantity of radiation (Includes devices such as phototimers and ion chambers).
"Automatic exposure rate control (AERC)" means a device which automatically controls one or more technique factors in order to obtain, at a preselected location(s), a required quantity of radiation per unit time.
"Barrier" (See "Protective barrier").
"Beam axis" means a line from the source through the centers of the x-ray fields.
"Beam-limiting device" means a device which provides a means to restrict the dimensions of the x- ray field.
"Bone densitometry system" means a medical device which uses electronically-produced ionizing radiation to determine the density of bone structures of human patients.
"C-arm fluoroscope" means a fluoroscopic x-ray system in which the image receptor and the x-ray tube housing assembly are connected or coordinated to maintain a spatial relationship. Such a system allows a change in the direction of the beam axis with respect to the patient without moving the patient.
"Cantilevered tabletop" means a tabletop designed such that the unsupported portion can be extended at least 100 cm beyond the support.
"Cassette holder" means a device, other than a spot-film device, that supports and/or fixes the position of an x-ray film [imaging] cassette during an x-ray exposure.
"Coefficient of variation (C)" means the ratio of the standard deviation to the mean value of a population of observations. It is estimated using the following equation:
= ith observation in sample;
"Computed tomography (CT)" means the production of a tomogram by the acquisition and computer processing of x-ray transmission data.
"Control panel" means that part of the x-ray control upon which are mounted the switches, knobs, pushbuttons, and other hardware necessary for manually setting the technique factors.
"Cooling curve" means the graphical relationship between heat units stored and cooling time.
"Cradle" means:
"CT" (See "Computed tomography").
"CT gantry" means tube housing assemblies, beam-limiting devices, detectors, and the supporting structures, frames, and covers which hold and/or enclose these components.
"Cumulative air kerma" means the total air kerma accrued from the beginning of an examination or procedure and includes all contributions from fluoroscopic and radiographic irradiation.
"Detector" (See "Radiation detector")
"Diagnostic source assembly" means the tube housing assembly with a beam-limiting device attached.
"Diagnostic x-ray system" means an x-ray system designed for irradiation of any part of the human [or animal] body for the purpose of diagnosis or visualization.
"Direct scattered radiation" means that scattered radiation which has been deviated in direction only by materials irradiated by the useful beam (See "Scattered radiation").
"Dose" means the absorbed dose as defined by the International Commission on Radiation Units and Measurements. The absorbed dose, D, is the quotient of de by dm, where de is the mean energy imparted to matter of mass dm; thus D=de/dm, in units of J/kg, where the special name of the unit of absorbed dose is gray (Gy).
"Equipment" (See "X-ray equipment").
"Exposure (X)" means the quotient of dQ by dm where dQ is the absolute value of the total charge of the ions of one sign produced in air when all the electrons and positrons liberated or created by photons in air of mass dm are completely stopped in air; thus X=dQ/dm, in units of C/kg. A second meaning of exposure is the process or condition during which the x-ray tube produces x-ray radiation.
"Field emission equipment" means equipment which uses an x-ray tube in which electron emission from the cathode is due solely to the action of an electric field.
"Filter" means material placed in the useful beam to preferentially absorb selected radiations.
"Fluoroscopic air kerma display devices" means separate devices, subsystems, or components that provide the display of AKR and cumulative air kerma, respectively, required by 5.0. They include radiation detectors, if any, electronic and computer components, associated software, and data displays.
"Fluoroscopic imaging assembly" means a subsystem in which x-ray photons produce a set of fluoroscopic images or radiographic images recorded from the fluoroscopic image receptor. It includes the image receptor(s), electrical interlocks, if any, and structural material providing linkage between the image receptor and diagnostic source assembly.
"Fluoroscopic irradiation time" means the cumulative duration during an examination or procedure of operator-applied continuous pressure to the device, enabling x-ray tube activation in any fluoroscopic mode of operation.
"Fluoroscopy" means a technique for generating x-ray images and presenting them simultaneously and continuously as visible images. This term has the same meaning as the term “radioscopy” in the standards of the International Electrotechnical Commission.
"Focal spot (actual)" means the area projected on the anode of the x-ray tube bombarded by the electrons accelerated from the cathode and from which the useful beam originates.
"General purpose radiographic x-ray system" means any radiographic x-ray system which, by design, is not limited to radiographic examination of specific anatomical regions.
"Gonad shield" means a protective barrier for the testes or ovaries.
"Half-value layer (HVL)" means the thickness of specified material which attenuates the beam of radiation to an extent such that the AKR is reduced by one-half of its original value. In this definition, the contribution of all scattered radiation, other than any which might be present initially in the beam concerned, is deemed to be excluded.
"Hand-held x-ray equipment" means x-ray equipment that is designed to be hand-held during operation.
"Healing arts screening" means the testing of human beings using x-ray machines for the detection or evaluation of health indications when such tests are not specifically and individually ordered by a licensed practitioner of the healing arts legally authorized to prescribe such x-ray tests for the purpose of diagnosis or treatment.
"Heat unit" means a unit of energy equal to the product of the peak kilovoltage, milliamperes, and seconds, i.e., kVp x mA x second.
"HVL" (See "Half-value layer").
"Image intensifier" means a device, installed in its housing, which instantaneously converts an x-ray pattern into a corresponding light image of higher intensity.
"Image receptor" means any device, such as a fluorescent screen, radiographic film, x-ray image intensifier tube, solid-state detector, or gaseous detector which transforms incident x-ray photons either into a visible image or into another form which can be made into a visible image by further transformations. In those cases where means are provided to preselect a portion of the image receptor, the term “image receptor” shall mean the preselected portion of the device.
"Image receptor support device" means, for mammography x-ray systems, that part of the system designed to support the image receptor during a mammographic examination and to provide a primary protective barrier.
"Irradiation" means the exposure of matter to ionizing radiation.
"Isocenter" means the center of the smallest sphere through which the beam axis passes when the equipment moves through a full range of rotations about its common center.
"Kerma" means the quantity defined by the International Commission on Radiation Units and Measurements. The kerma, K, is the quotient of dEtr by dm, where dEtr is the sum of the initial kinetic energies of all the charged participles liberated by uncharged particles in a mass dm of material; thus K=dEtr/dm, in units of J/kg, where the special name for the unit of kerma is gray (Gy). When the material is air, the quantity is referred to as “air kerma.”
"Kilovolts peak" (See "Peak tube potential").
"kV" means kilovolts.
"kVp" (See "Peak tube potential").
"kWs" means kilowatt second.
"Last image hold (LIH) radiograph" means an image obtained either by retaining one or more fluoroscopic images, which may be temporarily integrated, at the end of a fluoroscopic exposure or by initiating a separate and distinct radiographic exposure automatically and immediately in conjunction with termination of the fluoroscopic exposure.
"Lateral fluoroscope" means the x-ray tube and image receptor combination in a biplane system dedicated to the lateral projection. It consists of the lateral x-ray tube housing assembly and the lateral image receptor that are fixed in position relative to the table with the x-ray beam axis parallel to the plane of the table.
"Lead equivalent" means the thickness of lead affording the same attenuation, under specified conditions, as the material in question.
"Leakage radiation" means radiation emanating from the diagnostic source assembly except for:
"Leakage technique factors" means the technique factors associated with the diagnostic source assembly which are used in measuring leakage radiation. They are defined as follows:
"Licensed Practitioner" means an individual licensed to practice medicine, dentistry, dental hygiene, podiatry, chiropractic, or osteopathy in this State.
"Light field" means that area of the intersection of the light beam from the beam-limiting device and one of the set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the illumination is one-fourth of the maximum in the intersection.
"Line-voltage regulation" means the difference between the no-load and the load line potentials expressed as a percent of the load line potential , as follows:
Vn = No-load line potential; and
Vl = Load line potential.
"mA" means milliampere.
mAs" means milliampere second.
"Mobile x-ray equipment" (See "X-ray equipment").
"Mode of operation" means, for fluoroscopic systems, a distinct method of fluoroscopy or radiography provided by the manufacturer and selected with a set of several technique factors or other control settings uniquely associated with the mode. The set of distinct technique factors and control settings for the mode may be selected by the operation of a single control. Examples of distinct modes of operation include normal fluoroscopy (analog or digital), high-level control fluoroscopy, cineradiography (analog and digital), digital subtraction angiography, electronic radiography using the fluoroscopic image receptor, and photospot recording. In a specific mode of operation, certain system variables affecting kerma, AKR, or image quality, such as image magnification, x-ray field size, pulse rate, pulse duration, number of pulses, source-image receptor distance (SID), or optical aperture, may be adjustable or may vary; their variation per se does not comprise a mode of operation different from the one that has been selected.
"Movable tabletop" means a tabletop which, when assembled for use, is capable of movement with respect to its supporting structure within the plane of the tabletop.
"Non-image-intensified fluoroscopy" means fluoroscopy using only a fluorescent screen.
"Patient" means an individual or animal subjected to healing arts examination, diagnosis or treatment.
"PBL" See "Positive beam limitation."
"Peak tube potential" means the maximum value of the potential difference across the x-ray tube during an exposure.
"Phantom" means a volume of material behaving in a manner similar to tissue with respect to the attenuation and scattering of radiation. This requires that both the atomic number (Z) and the density of the material be similar to that of tissue.
"PID" (See "Position indicating device").
"Portable x-ray equipment" (See "X-ray equipment").
"Position indicating device" means a device on dental x-ray equipment used to indicate the beam position and to establish a definite source-surface (skin) distance. It may or may not incorporate or serve as a beam-limiting device.
"Positive beam limitation" means the automatic or semi-automatic adjustment of an x-ray beam to the size of the selected image receptor, whereby exposures cannot be made without such adjustment.
"Primary protective barrier" means the material, excluding filters, placed in the useful beam to reduce the radiation exposure [beyond the patient and cassette holder] for protection purposes.
"Protective apron" means an apron made of radiation absorbing materials used to reduce radiation exposure.
"Protective glove" means a glove made of radiation absorbing materials used to reduce radiation exposure.
"Pulsed mode" means operation of the x-ray system such that the x-ray tube current is pulsed by the x-ray control to produce one or more exposure intervals of duration less than one-half second.
Qualified expertmeans an individual who has demonstrated to the satisfaction of the Agency that such individual possesses the knowledge and training to measure ionizing radiation, to evaluate safety techniques, and to advise regarding radiation protection needs, for example, individuals certified in the appropriate field by the American Board of Radiology, or the American Board of Health Physics, or the American Board of Medical Physics, or those having equivalent qualifications. With reference to the calibration of radiation therapy equipment, an individual, in addition to the above qualifications, must be qualified in accordance with Part X.
"Qualified medical physicist" means an individual who meets the requirements specified in Part X.
"Quick change x-ray tube" means an x-ray tube designed for use in its associated tube housing such that:
"Radiation detector" means a device which in the presence of radiation provides a signal or other indication suitable for use in measuring one or more quantities of incident radiation.
"Radiation therapy simulation system" means a radiographic or fluoroscopic x‑ray system intended for localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field.
"Radiograph" means an image receptor on which the image is created directly or indirectly by an x-ray pattern and results in a permanent record.
"Radiography" means a technique for generating and recording an x-ray pattern for the purpose of providing the user with an image(s) after termination of the exposure.
"Rated line voltage" means the range of potentials, in volts, of the supply line specified by the manufacturer at which the x-ray machine is designed to operate.
"Rated output current" means the maximum allowable load current of the x-ray high-voltage generator.
"Rating" means the operating limits specified by the manufacturer.
"Recording" means producing a retrievable form of an image resulting from x-ray photons.
"Scan" means the complete process of collecting x-ray transmission data for the production of a tomogram. Data may be collected simultaneously during a single scan for the production of one or more tomograms.
"Scan time" means the period of time between the beginning and end of x-ray transmission data accumulation for a single scan.
"Scattered radiation" means radiation that, during passage through matter, has been deviated in direction (See "Direct scattered radiation").
"Shutter" means a device attached to the tube housing assembly which can intercept the entire cross sectional area of the useful beam and which has a lead equivalency not less than that of the tube housing assembly.
"SID" (See "Source-image receptor distance").
"Solid state x-ray imaging device" means an assembly, typically in a rectangular panel configuration, that intercepts x-ray photons and converts the photon energy into a modulated electronic signal representative of the x-ray intensity over the area of the imaging device. The electronic signal is then used to create an image for display and/or storage.
"Source" means the focal spot of the x-ray tube.
"Source-image receptor distance" means the distance from the source to the center of the input surface of the image receptor.
"Source-skin distance (SSD)" means the distance from the source to the center of the entrant x-ray field in the plane tangent to the patient skin surface.
"Spot film" means a radiograph which is made during a fluoroscopic examination to permanently record conditions which exist during that fluoroscopic procedure.
"Spot-film device" means a device intended to transport and/or position a radiographic image receptor between the x-ray source and fluoroscopic image receptor. It includes a device intended to hold a cassette over the input end of the fluoroscopic image receptor for the purpose of producing a radiograph.
"Stationary tabletop" means a tabletop which, when assembled for use, is incapable of movement with respect to its supporting structure within the plane of the tabletop.
"Stationary x-ray equipment" (See "X-ray equipment").
"Stray radiation" means the sum of leakage and scattered radiation.
"Technique factors" means the following conditions of operation:
"Tomogram" means the depiction of the x-ray attenuation properties of a section through the body.
"Tube" means an x-ray tube, unless otherwise specified.
"Tube housing assembly" means the tube housing with tube installed. It includes high-voltage and/or filament transformers and other appropriate elements when such are contained within the tube housing.
"Tube rating chart" means the set of curves which specify the rated limits of operation of the tube in terms of the technique factors.
"Useful beam" means the radiation which passes through the tube housing port and the aperture of the beam limiting device when the exposure switch or timer is activated.
"Variable-aperture beam-limiting device" means a beam-limiting device which has capacity for stepless adjustment of the x-ray field size at a given SID.
"Visible area" means that portion of the input surface of the image receptor over which incident x-ray photons are producing a visible image.
"X-ray control" means a device which controls input power to the x-ray high-voltage generator and/or the x-ray tube. It includes equipment such as timers, phototimers, automatic brightness stabilizers, and similar devices, which control the technique factors of an x-ray exposure.
"X-ray exposure control" means a device, switch, button or other similar means by which an operator initiates and/or terminates the radiation exposure. The x-ray exposure control may include such associated equipment as timers and back-up timers.
"X-ray equipment" means an x-ray system, subsystem, or component thereof. Types of x-ray equipment are as follows:
"X-ray field" means that area of the intersection of the useful beam and any one of a set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the AKR is one-fourth of the maximum in the intersection.
"X-ray high-voltage generator" means a device which transforms electrical energy from the potential supplied by the x-ray control to the tube operating potential. The device may also include means for trans­forming alternating current to direct current, filament transformers for the x-ray tube(s), high-voltage switches, electrical protective devices, and other appropriate elements.
"X-ray subsystem" means any combination of two or more components of an x-ray system for which there are requirements specified in this section and 4.0, 5.0, 6.0.
"X-ray system" means an assemblage of components for the controlled production of x-rays. It includes minimally an x-ray high-voltage generator, an x-ray control, a tube housing assembly, a beam-limiting device, and the necessary supporting structures. Additional components which function with the system are considered integral parts of the system.
"X-ray table" means a patient support device with its patient support structure (tabletop) interposed between the patient and the image receptor during radiography and/or fluoroscopy. This includes, but is not limited to, any stretcher equipped with a radiolucent panel and any table equipped with a cassette tray (or bucky), cassette tunnel, fluoroscopic image receptor, or spot-film device beneath the tabletop.
"X-ray tube" means any electron tube which is designed for the conversion of electrical energy into x-ray energy.
3.2.1.3 The temperature of solutions in the tanks shall be maintained within the range of 60o F to 80o F (16o C to 27o C). Film shall be developed in accordance with the time-temperature relationships recommended by the film manufacturer, or, in the absence of such recommendations, with the following time-temperature chart:
oC
oF
oC
oF
a/ Immersion time only, no crossover time included.
6.4.1 Equipment having independent selection of x-ray tube current (mA). The average ratios of air kerma to the indicated milliampere-seconds product (mGy/mAs) obtained at any two consecutive tube current settings shall not differ by more than 0.10 times their sum. This is: ׀X1 – X2׀ ≤ 0.10(X1 + X2); where X1 and X2 are the average mGy/mAs values obtained at each of two consecutive mAs selector settings or at two settings differing by no more than a factor of 2 where the mAs selector provides continuous selection.
6.4.2 Equipment having selection of x-ray tube current-exposure time product (mAs). For equipment manufactured after May 3, 1994, the average ratios of air kerma to the indicated milliampere-seconds product (mGy/mAs) obtained at any two consecutive mAs selector settings shall not differ by more than 0.10 times their sum. This is: ׀X1 – X2׀ ≤ 0.10(X1 + X2); where X1 and X2 are the average mGy/mAs values obtained at each of two consecutive mAs selector settings or at two settings differing by no more than a factor of 2 where the mAs selector provides continuous selection.
"Computed tomography dose index" (CTDI) means the integral of the dose profile along a line perpendicular to the tomographic plane divided by the product of the nominal tomographic section thickness and the number of tomograms produced in a single scan, that is:
where:
"Contrast scale" means the change in the linear attenuation coefficient per CTN relative to water, that is:
where:
"CT conditions of operation" means all selectable parameters governing the operation of a CT x-ray system including nominal tomographic section thickness, filtration, and the technique factors as defined in 2.0.
"CT dosimetry phantom" means the phantom used for determination of the dose delivered by a CT x-ray system. The phantom shall be a right circular cylinder of polymethl-methacrylate of density 1.19±0.01 grams per cubic centimeter. The phantom shall be at least 14 centimeters in length and shall have diameters of 32.0 centimeters for testing any CT system designed to image any section of the body (whole body scanners) and 16.0 centimeters for any system designed to image the head (head scanners) or for any whole body scanner operated in the head scanning mode. The phantom shall provide means for the placement of a dosimeter(s) along its axis of rotation and along a line parallel to the axis of rotation 1.0 centimeter from the outer surface and within the phantom. Means for the placement of a dosimeter(s) or alignment device at other locations may be provided for convenience. Any effect on the doses measured due to the removal of phantom material to accommodate dosimeters shall be accounted for through appropriate corrections to the reported data or included in the statement of maximum deviation for the values obtained using the phantom.
"CT Number" means the number used to represent the x-ray attenuation associated with each elemental area of the CT image:
where:
"Dose profile" means the dose as a function of position along a line.
"Modulation transfer function" means the modulus of the Fourier transform of the impulse response of the system.
"Multiple tomogram system" means a computed tomography x-ray system which obtains x-ray transmission data simultaneously during a single scan to produce more than one tomogram.
"Noise" means the standard deviation of the fluctuations in CTN expressed as a percentage of the attenuation coefficient of water. Its estimate (Sn) is calculated using the following expression:
where:
"Nominal tomographic section thickness" means the full width at half-maximum of the sensitivity profile taken at the center of the cross-sectional volume over which x-ray transmission data are collected.
"Picture element" means an elemental area of a tomogram.
"Reference plane" means a plane which is displaced from and parallel to the tomographic plane.
"Remanufacturing" means modifying a CT system in such a way that the resulting dose and imaging performance become substantially equivalent to any CT x-ray system manufactured by the original manufacturer on or after November 29, 1984. Any reference in this subsection to “manufacture,” “manufacturer,” or “manufacturing” includes remanufacture, remanufacturing, respectively.
"Scan" means the complete process of collecting x-ray transmission data for the production of a tomogram. Data can be collected simultaneously during a single scan for the production of one or more tomograms.
"Scan increment" means the amount of relative displacement of the patient with respect to the CT x-ray system between successive scans measured along the direction of such displacement.
"Scan sequence" means a pre-selected set of two or more scans performed consecutively under pre-selected CT conditions of operation.
"Sensitivity profile" means the relative response of the CT x-ray system as a function of position along a line perpendicular to the tomographic plane.
"Single tomogram system" means a CT x-ray system which obtains x-ray transmission data during a scan to produce a single tomogram.
"Tomographic plane" means that geometric plane which the manufacturer identified as corresponding to the output tomogram.
"Tomographic section" means the volume of an object whose x-ray attenuation properties are imaged in a tomogram.
8.12.6.2 The CTDI2/ along the two axes specified in Subdivision 8.12.4.2 shall be measured. The CT dosimetry phantom shall be oriented so that the measurement point 1.0 centimeter from the outer surface and within the phantom is in the same angular position within the gantry as the point of maximum surface CTDI identified. The CT conditions of operation shall correspond to typical values used by the registrant;